title: Three Rs Approaches in the Production and Quality Control of Fish Vaccines.
abstract: The workshop on Three Rs Approaches in the Production and Quality Control of Fish Vaccines aimed a) to identify animal tests currently stipulated for the production and quality control of fish vaccines and to highlight animal welfare concerns associated with these tests; b) to identify viable options to replace, reduce, and refine animal use for fish vaccine testing; and c) to discuss the way forward and set out how the Three Rs may be implemented without jeopardizing the quality of the vaccines. The workshop participants - experts from academia, regulatory authorities, a scientific animal welfare organization, and the fish vaccine industry - agreed that efforts should be undertaken to replace the vaccination-challenge batch potency testing with tests based on antigen quantification or antibody response tests. Regulatory requirements of questionable scientific value and relevance for the quality of fish vaccines, such as the re-testing of batches produced outside Europe, or the double-dose batch safety test, should be re-considered. As an immediate measure the design of the current animal tests should be evaluated and modified in the light of refinement and reduction, for example, the number of unprotected control fish in vaccination-challenge tests should be reduced to the minimum.
authors.affiliation: VESO, P.O. Box 300 Sentrum, 0103 Oslo, Norway.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Midtlyng
authors.forename: Coenraad
authors.initials: C
authors.lastname: Hendriksen
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Balks
authors.forename: Lukas
authors.initials: L
authors.lastname: Bruckner
authors.forename: Lawrence
authors.initials: L
authors.lastname: Elsken
authors.forename: Oystein
authors.initials: O
authors.lastname: Evensen
authors.forename: Kjetil
authors.initials: K
authors.lastname: Fyrand
authors.forename: Allison
authors.initials: A
authors.lastname: Guy
authors.forename: Marlies
authors.initials: M
authors.lastname: Halder
authors.forename: Penny
authors.initials: P
authors.lastname: Hawkins
authors.forename: Gunn
authors.initials: G
authors.lastname: Kisen
authors.forename: Anne Berit
authors.initials: AB
authors.lastname: Romstad
authors.forename: Kira
authors.initials: K
authors.lastname: Salonius
authors.forename: Patrick
authors.initials: P
authors.lastname: Smith
authors.forename: Lynne U
authors.initials: LU
authors.lastname: Sneddon
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards*; D000818:Animals; D018929:Cell Culture Techniques / Q000379:methods / Q000592:standards / Q000639:trends; D002478:Cells, Cultured; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000662:veterinary; D005393:Fish Diseases / Q000276:immunology / Q000628:therapy*; D005399:Fishes / Q000276:immunology; D007107:Immune System / Q000502:physiology; D007880:Legislation, Drug; D008004:Licensure; D011786:Quality Control; D014612:Vaccines / Q000009:adverse effects / Q000096:biosynthesis* / Q000302:isolation & purification* / Q000627:therapeutic use*
chemical_list: D014612:Vaccines